Monday, November 18, 2013

HOT off PRESS! Law of Compounding Medicines and Drugs Interview with Dr. Sarah Sellers Regarding the Recent Passage of the Drug Clarity and Security Act (DCSA), HR 3204

This blog had the privilege and honor of being able to interview Sarah Sellers, PharmD, MPH. about the recent passage of the Drug Clarity and Security Act (DCSA) by Congress.  Dr. Sellers is a well-recognized and respected pharmacoepidemiologist and advisor on safety concerns related to both FDA-approved and pharmacy compounded drugs. 

Dr. Sellers has been dealing with compounding issues for a while now.  She has worked both for the FDA and in private industry.  She was on the FDA advisors and consultants staff (pharmacy compounding, dermatologic and risk management) from 1998 to 2005; the FDA office of compliance from 2006-2007, and the FDA office of surveillance and epidemiology from  2007-2008.  Dr. Sellers has provided oral and written testimony to U.S. Congressional Committees.  Since the NECC outbreak, we have all realized that   “If Sarah Sellers' warnings had been taken seriously 10 years ago, 12 people might be alive today.”  See Elizabeth Cohen. Danielle Dellorto and William Hudson, Meningitis outbreak highlights failed oversight efforts CNN  (October 10, 2012).   

She is currently the President of q-Vigilance, LLC, and is also a founding member and one of the leaders of the Working Group on Pharmaceutical Safety, a group created to address serious gaps in current policy that led to a dangerous increase in the volume of mass-manufactured pharmaceutical products in the United States created under the guise of pharmacy compounding.  Here is Dr. Sellers' interview:  

Sue:   Today the United States Congress passed the Drug Clarity and Security Act.  It is anticipated the President will sign this legislation into law later this week.  You have worked many years, including working for the FDA and testifying before Congress, to make the public aware of the dangers associated with compounded medications and to have better oversight in this area.  Do you think Congress has finally taken a step in the right direction?

Dr. Sellers:  Congress has taken more than just a step—the new law is a direct and proportional response to the nation’s iatrogenic fungal meningitis outbreak, which continues to impact the lives and livelihood of patients and their families, across the nation.  The uncertainty and ambiguity around original compounding legislation has been resolved, and its original integrity restored, with additional provisions that further protect the public health.   Importantly, in direct response to the NECC outbreak, an additional layer of GMP oversight is made available through registration with FDA, for outsourcing pharmacies that reconstitute, admix and sell FDA-approved products, or that manufacture and sell drugs during listed shortages, in a non-patient specific manner to hospitals and clinics.  

Sue:  Obviously there are critics of the federal legislation and no piece of legislation is perfect, but what in your opinion is the most benefical part of this legislation?

Dr. Sellers:  The NECC sentinel event was specific to outsourcing pharmacies, which may have led to new definitions, or a distortion of historical definitions, for traditional pharmacy practice.  The restoration and augmentation of the original compounding legislation is very important in this regard, because it holds in check the delicate balance that is necessary to make compounded medications available for individual, medically necessary circumstances, while at the same time ensuring that the vast majority of medications that are made accessible for use in US populations have been reviewed by FDA for safety, efficacy and manufacturing quality.  

Sue:  Do you think the FDA currently has the resources and expertise to implement this new piece of legislation?

Dr. Sellers:  I’ve had the great fortune and privilege of working for the FDA—I know of no other environment with such concentrated expertise in medicine, science, and policy for implementing the legislation.  Resources are another matter.  The agency is underfunded to carry out its obligations to Congress and the citizens of the US and it must prioritize—this is one significant factor that can lead to “capture” by regulated industries.  Congress’s obligations don’t end with the bill’s passage—ensuring the law is properly implemented, and that both states and the FDA have resources to enforce, will be their on-going challenge and responsibility.  

Sue:  Do you think state boards of pharmacy still have a crucial role  to play in regulating compounded medications? What is that role or what can they do to help prevent another NECC outbreak?  

Dr. Sellers:  State Boards of Pharmacy are on the frontline of pharmacy practice and serve a crucial role in protecting public health.  It is important to recognize, and take advantage of, differences in the regulation of a professional practice, and the regulation of the safety, efficacy and manufacturing quality of medications—these are complementary regulatory functions, that, when aligned and working together, form a robust oversight infrastructure.  

Sue:  You have worked with victims from the NECC outbreak.  What suggestions do you have for consumers to make sure they don't become a victim of another NECC?   

Dr. Sellers:  If there is an overriding medical need to prescribe or administer a non-FDA-approved product for the treatment of an individual, medical prescribers and pharmacists should engage patients in an informed consent or informed decision-making process that includes discussion of the potential benefits and risks of drug and non-drug therapeutic options.  This falls under the direct scope of the compounding triad (prescriber, patient and pharmacist decision-making), medication counseling and the provision of good pharmaceutical care.  Boards of Pharmacy and Medicine have direct responsibility for ensuring professionals adhere to basic medical/pharmacy ethics, but, if this is not happening, consumers need to ask—their life may depend on it.  

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